drugset / Trial / NCT01111825
Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or triple-negative disease.
Timeline
- Start
- 2010-04
- Primary completion
- 2016-07
- Completion
- 2016-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neratinib | Small molecule | 240 mg | Oral |
| Subject | Temsirolimus | Small molecule | 8 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 15 mg | Intravenous |